India - Hyderabad JOB ID R-221618 ADDITIONAL LOCATIONS India - Hyderabad WORK LOCATION TYPE On Site DATE POSTED Jul 25 2025 CATEGORY Quality Join Amgen s Mission of Serving Patients At Amgen if you feel like you re part of something bigger it s because you are Our shared mission to serve patients living with serious illnesses drives all that we do Since 1980 we ve helped pioneer the world of biotech in our fight against the world s toughest diseases With our focus on four therapeutic areas -Oncology Inflammation General Medicine and Rare Disease- we reach millions of patients each year As a member of the Amgen team you ll help make a lasting impact on the lives of patients as we research manufacture and deliver creative medicines to help people live longer fuller happier lives Our award-winning culture is collaborative innovative and science based If you have a passion for challenges and the opportunities that lay within them you ll thrive as part of the Amgen team Join us and transform the lives of patients while transforming your career Position Summary The AIN Sr Associate QA plays a critical role in supporting disposition related tasks across the Amgen Quality Operations Network The Senior Associate QA will leverage industry technical and quality systems knowledge to provide support of business performance and GMP disposition supporting processes across the network The position will be responsible for tasks including the key responsibilities documented below and other disposition related job functions This candidate will primarily work during regular working hours 9 am - 6 PM local time to enable the business in delivering Amgen s mission to serve patients and may lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones The candidate may need to work outside of his her routine workday to support business needs and will be responsible for determining the same for their staff The individual will be required to work from our office located in Hyderabad India Amgen India-AIN The candidate will also lead the remote support from AIN to Amgen sites across multiple time zones which will include the following locations US - California Puerto Rico North Carolina Ohio Rhode Island Ireland - Dun Laoghaire and Singapore Key Responsibilities Business Performance Facilitation of Amgen disposition network meeting including meeting planning preparation communication of meeting notes and action item tracking Create maintain and report monthly disposition metrics in support of all Amgen sites Create and sustain a visualization tool that displays the progress of each disposition element required for the disposition of a material and product batch Monitoring of material and product batches to confirm readiness for disposition Communicate to plants sites when there is a material or product batch priority Technical Writing and Document Management Maintenance periodic review and revision of GMP procedures supporting global and site level disposition processes Generate Production and Disposition summary to support the Annual Product Review APR Perform data verification review approval Quality Systems and Clinical Disposition Process Support Management and periodic review of badge access to controlled GMP areas Periodic SAP security audits and access review for Amgen sites Execution of GMP process for adding countries branches or studies to a clinical drug Product FDP batch in the ERP system as regulatory approvals are received Inspection Request Form IRF pre-request support Support readiness for internal and external audits and inspections including the provision of pre-inspection request documents such as disposition document lists and disposition lot lists Support of information requests and response preparation during audits and inspections execution through the provision of disposition related information and data Preferred Qualifications Experience in project management and related systems Proficiency in technical writing and data visualization tools experience with Smartsheet Tableau or equivalent platforms preferred Strong analytical skills with the ability to interpret data and draw conclusions Excellent verbal and written communication skills Proven ability to lead and collaborate within cross-functional teams in a dynamic fast-paced setting Core Competencies Organizational Agility Business Operations and Project Support Experience working in a regulated environment with knowledge of Good Manufacturing Practice GMP and Good Documentation Practice GDP requirements Experience working with Quality Systems that may include enterprise resource planning ERP SAP regulatory information management RIM controlled document management CDOCs change control CCMS deviation and or quality control laboratory information management systems LIMS Technical Document Drafting and Workflow Ownership Data Visualization Interpretation and Analytics Basic Qualifications and Experience Master s degree with 5-8 years of Pharma and Biotech commercial or clinical manufacturing Quality experience

📌 Sr Associate Qa (Telangana)
🏢 AMGEN
📍 Telangana